Io, while I share your views on the relative transparency of this anemia trial, I took Clark's words of caution to heart and reviewed all the data I have... and continue to see no problems. He laments that there is no one on this board dissecting the anemia trial like they're doing (and have been doing for the past year to the tune of thousands of posts regarding the chances of hitting the interim, etc, etc, etc) on the DNDN board regarding it's IMPACT trial. I'd say that's for very obvious reasons... neither DNDN's data nor its management is as clear and as simple as is the case with RPRX... it's just a far simpler problem.
In fact, after reviewing all the info I have (to the degree I'm capable), I have only one question for Docbanker, and that regards Dewo's concern about the FDA's possible downstream view wrt chronic use and it's possible side-effects (Dewophile post #3585: "it's possible for the anemia indication to get approval and then fail on the chronic indication,). He goes on to state (there and elsewhere) that he doesn't believe that it's really a problem, but in fact it's a valid concern, as it's the only part of the trail matrix that hasn't already been demonstrated in earlier trials.
The question I have goes to that concern (posted above): Do the 29 women who have successfully tracked through 3 treatment cycles (slide 26 of Pa-zzaz presentation) without problems represent all of the women who have gotten to that point at this time? What happened to the other 40 women in the drug legs of the study (ZPU-003)(.67 * 127 – 16 – 29 = 40). Did they go off drug entirely after the trial? Are they being tracked? Are there, in a Clarkian world of idiots and scammers running biotechs, a bunch of women out there that FAILED to successfully come off drug and resume normal menses that we haven't been told about?
While I seriously doubt it, I would like to know the answer to that question as surely as I know the answers to the efficacy and safety aspects in all other regards... but that's all I could honestly come up with. As to whether the types of concerns voiced by others here bother me (equivalent cohorts for the anemia as the earlier trials, u.s. vs. ex-U.S, 25 vs. 50 mg dosing, etc)... just call me a MAD magazine reader!
AI
